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Fentora is a medicine used to manage breakthrough cancer pain in people who are already taking other narcotic painkillers around-the-clock for their cancer pain. Fentora is started only after you have been taking other narcotic painkillers and your body has become used to them (you are "opioid-tolerant").
Fentora is a federally controlled substance because it has abuse potential.
How does this medication work?
Fentora works in your central nervous system (the brain and spinal cord) and affects the way your body responds to pain.
Fentora is not used to treat pain that you have after surgery if the pain is mild or not expected to last for a long period.
What are the beneficial effects of this medication and when should I begin to have results?
What: Fentora has been shown to help relieve pain.
When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's directions. It is important that you take Fentora exactly as your healthcare provider has prescribed.
How do I know it is working?
You may feel an improvement in your pain. This is a good indicator that the medicine is working. Your healthcare provider may also ask you questions from time to time to assess how well your symptoms are controlled with treatment.
The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.
Due to the risk of serious, life-threatening breathing problems, do not use Fentora unless you are regularly using another narcotic painkiller around-the-clock for at least one week or longer for your cancer pain and your body is used to these medicines. Also, do not use Fentora to treat pain after surgery if the pain is mild or not expected to last for a long period (including headaches or migraines). Tell your healthcare provider right away if you are breathing more slowly than usual; are experiencing shallow breathing (little chest movement while breathing); or if you feel faint, dizzy, confused, or have any other unusual symptoms.
Keep Fentora in a safe place, away from children. Accidental use may result in serious harm and may be life-threatening.
Fentora has abuse potential. If you have concerns, talk to your healthcare provider for more information about abuse and addiction. Do not share Fentora with others and take steps to protect Fentora from theft or misuse.
Fentora is available only through a program called the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access Program. Under this program, you must talk to your healthcare provider, understand the benefits and risks of Fentora, agree to all the instructions, and sign the Patient-Prescriber Agreement form in order to receive Fentora.
More common side effects may include: nausea; dizziness; vomiting; tiredness; low red blood cell counts; constipation; swelling in your arms, hands, legs, or feet; weakness; dehydration; headache.
Less common side effects may include:
Fentora may decrease your heart rate.
Fentora may cause pain, irritation, or sores at the application site (on your gum, on the inside of your cheek, or under your tongue). Tell your healthcare provider if this is a problem for you.
Do not use Fentora if you are allergic to it or any of its ingredients.
Do not use Fentora if you are not opioid-tolerant.
Do not use Fentora to treat short-term pain that would go away in a few days, such as pain after surgery, headache or migraine, or dental pain.
Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Fentora. Also, talk to your healthcare provider about your complete medical history, especially if you have trouble breathing or lung problems (such as asthma, wheezing, or shortness of breath); a head injury or brain problems; liver or kidney problems; seizures; a slow heart rate or other heart problems; low blood pressure; mental health problems (such as major depression, schizophrenia, or hallucinations); a history of drug or alcohol addiction or a family history of these problems; or if you are pregnant, plan to become pregnant, or are breastfeeding.
The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.
Adults: The starting dose is 100 micrograms. Your healthcare provider may increase your dose as needed, until the desired effect is achieved.
It is important that you do not stop taking this medication abruptly. If you need to change or stop taking this medication, it is important that you only do this with the guidance of your healthcare provider.
Take Fentora exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Fentora without first talking to your healthcare provider.
Take Fentora tablets whole. If you crush, split, suck, or chew Fentora tablets, you will get less pain relief.
Each Fentora tablet should be left between your cheek and gum or under your tongue until it has disintegrated, which usually takes about 14-25 minutes. After 30 minutes, any pieces of Fentora that remain may be swallowed with a glass of water.
Use one dose of Fentora for each episode of breakthrough cancer pain. If your breakthrough cancer pain does not get better 30 minutes after taking the first dose of Fentora, you can use only one more dose of Fentora, as instructed by your healthcare provider. If your breakthrough pain does not get better after the second dose, call your healthcare provider for instructions. Do not use another dose of Fentora at this time.
Wait at least 4 hours before treating a new episode of breakthrough cancer pain with Fentora. Talk to your healthcare provider if you have more than 4 episodes of breakthrough cancer pain per day. The dose of your around-the-clock pain medicine may need to be adjusted.
Please review the instructions that came with your prescription on how to properly use Fentora.
To dispose of unused Fentora tablets, remove the tablets from their package, and flush them down the toilet. Do not flush the Fentora packaging down the toilet.
Do not drive a car, operate machinery, or engage in other dangerous activities until you know how Fentora affects you.
Do not drink alcohol or take prescription or over-the-counter medicines that contain alcohol while you are taking Fentora.
Do not drink grapefruit juice while you are taking Fentora.
If Fentora is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Fentora may interact with numerous medications. Therefore, it is very important that you tell your healthcare provider about any other medications you are taking.
The effects of Fentora during pregnancy are unknown. Fentora can be found in your breast milk if you take it while breastfeeding. Do not take Fentora while you are breastfeeding. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
Fentora should be used under special circumstances determined by your healthcare provider. If you miss your scheduled dose, contact your healthcare provider or pharmacist for advice.
Store at room temperature. Protect from freezing and moisture.
In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
National Poison Control#: Call 1-800-222-1222
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